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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K090342
Device Name POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
Applicant
Sophysa SA
2884 Danapoplar
Dana Point,  CA  92629
Applicant Contact ESTHER SALTZ
Correspondent
Sophysa SA
2884 Danapoplar
Dana Point,  CA  92629
Correspondent Contact ESTHER SALTZ
Regulation Number882.5550
Classification Product Code
JXG  
Date Received02/10/2009
Decision Date 08/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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